achieve compliance, reduce risk, enhance safety
Rapid eDHR Solution
Values & Capabilities
Delivered by Manufacturing Experts
Track & Trace Genealogy
Electronic Device History Record (eDHR)
An electronic device history record (eDHR) allows manufacturers to collect and manage critical records required by the FDA to document the production of each device. By automating your device history record processes with an eDHR, you can more confidently achieve compliance with FDA cGMP requirements, reduce risk, and enhanced safety for medical device users. By bringing together all data about a device’s manufacturing and testing history, the eDHR tracks data to ensure the document process and compliance was followed. That includes the requirement that the components and materials approved for assembly into the product were the ones actually used, all tests passed, and that all workers involved in the manufacturing and testing processes were trained and certified on the required operations.
The Fastest, Easiest Way to Launch eDHR Quality Records
With the Rapid eDHR solution, you can jump-start your electronic record-keeping and begin to see advantages at your next compliance audit. The Rapid eDHR offering is part of the 42Q Cloud platform: a complete, scalable Cloud solution for managing global manufacturing operations.
• Tracking and Traceability
• Online Work Instructions
• Employee Verification
• 42Q Live and Operations Dashboard
• Standard Reports & Cycle Time Report
Trusted Partner Of
Our Customers Deploy in as Little as 6 Weeks
Our deployment services team is certified in our RPM (Rapid Production Model) implementation methodology and will guide you through a timely and effective deployment of 42Q.
See How Our Customers are
Transforming Their Businesses
Weir Minerals Reduces Manufacturing Lead Times by up to 30%
Weir Minerals, a part of the Weir Group plc, is a global market leader in the supply of engineered solutions and aftermarket products to the mining industry. Their customers require fast order fulfillment lead times, which are met by manufacturing products as quickly as possible within their 12 core manufacturing plants.
42Q Enables Production Readiness to Double the Volume at Comet’s Penang Facility
Comet’s facility in Penang, Malaysia needed to double the production volume of matching networks within a period of six months. While the manufacturing process itself could support the increase, the manual data collection process had reached the limits of its capability. The company needed to increase efficiency, improve quality, enhance traceability and wanted a single source of truth for all manufacturing data. They decided to implement a Manufacturing Execution System (MES) and eliminate all spreadsheet and paper based processes. They also wanted the system to seamlessly integrate with their ERP system and a variety of manufacturing equipment.
Cloud MES Supports Sophisticated Automation in a High Speed, Highly-Regulated Manufacturing Environment
A global medical device manufacturer had been producing complex Class II medical devices for years, using 42Q as their MES. Now they faced the challenge of manufacturing high-volume Class III medical devices with complex, fully automated production lines. They feared that implementing advanced, high-volume automation using 42Q MES would require significant factory downtime. The new production lines required a high level of sophisticated automation and a manufacturing execution system that supported and seamlessly integrated with such systems.
Digital Factory Transformation with 35,000 Pieces of Manufacturing Equipment Connected in the Cloud
Sanmina manufactures 250 million products per year. More of a challenge is that there are over 200,000 different top-level assemblies produced each year for 700 different OEM customers with up to 20,000 forecast changes per week. The OEMs operate in diverse industries including telecommunications, enterprise computing & storage, industrial and clean technology. A significant amount of production is for medical, aerospace and automotive products with strict regulatory requirements. The existing on-premise MES required significant maintenance and upgrade effort from the IT and operations teams. It was also limited in its ability to manage supply chains beyond the walls of each factory, and was not well suited for factory automation and other IIoT initiatives.